QA Release Responsible Parenterals
il y a 4 semaines
Within the quality department of Janssen Supply Chain in Beerse we are looking for a **QA Release Responsible Parenteral Products **for a permanent position._ _Are you an individual with an eye for detail, a passion for working in a sterile production environment and are you driven by quality?
Do you want to be part of Janssen Supply Chain in Beerse, the production department of Janssen Pharmaceutica, where 650 passionate employees give the best of themselves every day for patients worldwide? Then you're the one we're looking for
As QA release Responsible Parenteral Products, you will work in the sterile production plant, where formulation, filling, inspection and packaging of our sterile products takes place. These vital products are produced here on a daily basis at a fast pace and with high quality.
**Your function**:
- You put the patient first. You are responsible for the **release process **of parenteral products. You ensure that the semi-finished and finished products are produced and released according to the requirements and/or specifications of the relevant markets. You will set up agreements with the planning department. Good communication is key to ensure the continuity of the market supply and to avoid stock-out situations.
- You guarantee product quality. You are responsible for the support in investigating non-conformances during parenteral production. You will have quality oversight and support the investigation by connecting with all parties involved and documenting quality related decisions in a well-founded manner. You ensure that root cause analysis, impact analysis and corrective and preventive actions are thoroughly carried out and documented.
- You have a passion for quality and compliance. You are responsible for evaluating and approving **Change Controls **. You check whether the change has an impact on the production process, the quality of the product or the specifications of the materials used in accordance with the applicable procedures. You support in evaluating, handling and following up on **market complaints **related to the parenteral products. You ensure good communication with internal and external stakeholders and escalate when necessary.
- You challenge the status quo and **continuously seek to improve **. You proactively participate in improvement initiatives that guarantee the quality of the end product and strive for a decrease in the number of deviations and complaints.
- You have **strong communication skills **. You carry out control **tours and internal audits **in interaction with operations. You participate in the preparation of external and internal inspections that are part of general compliance and act as a spokesperson.
- You have a scientific university degree (or equivalent through experience).
- You are fluent in Dutch and English.
- You can deal with time pressure, changing priorities and unplanned issues. You have a can-do mentality.
- You are assertive and take decisions. You strive to deliver results and make progress.
- You are resilient. You take initiatives to improve your own behaviors, working methods, knowledge, and can adapt to changing circumstances.
- You can work well in a team while working independently and maintain an open and constructive dialogue with various partners.
- Quality is of paramount importance to you. You are familiar with GMP legislation and deliver accurate work.
- You are familiar with pharmaceutical product development, qualification, packaging, validation, testing, release and distribution processes. You have knowledge of aseptic processes and techniques. Experience with new product introductions is a plus.
- You have a pro-active attitude and are familiar with the risk management principles.
**Qualifications**:
- You have a scientific university degree (or equivalent through experience).
- You are fluent in Dutch and English.
- You can deal with time pressure, changing priorities and unplanned issues. You have a can-do mentality.
- You are assertive and take decisions. You strive to deliver results and make progress.
- You are resilient. You take initiatives to improve your own behaviors, working methods, knowledge, and can adapt to changing circumstances.
- You can work well in a team while working independently and maintain an open and constructive dialogue with various partners.
- Quality is of paramount importance to you. You are familiar with GMP legislation and deliver accurate work.
- You are familiar with pharmaceutical product development, qualification, packaging, validation, testing, release and distribution processes. You have knowledge of aseptic processes and techniques. Experience with new product introductions is a plus.
- You have a pro-active attitude and are familiar with the risk management principles.
**What can we offer you?**
In exchange for your talent, knowledge and passion for innovation and quality, we offer a position in a challenging environment.
In addition to a pleasant and res
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